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Allergy Skin Patch Artificial Intelligence (AI)

Primary Purpose

Allergic Contact Dermatitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AI-based smartphone application
Allergen patch
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Allergic Contact Dermatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria

  • Adults over the age of 18
  • Willing and able to provide informed consent

Exclusion Criteria

  • Under 18 years of age
  • Has used topical or oral steroids two weeks prior to patch testing
  • Currently taking immunosuppression agents or is immunocompromised due to medical condition
  • No sunburn or rash at site of testing
  • Women who are breastfeeding or pregnant.
  • Treatment with ultraviolet (UV) light (including tanning) during the two weeks prior to visit.
  • Subjects unable to comply with patch test study requirements including multiple return visits and activity restrictions (e.g., protecting patch test area from excess moisture due to showering)

Sites / Locations

  • Mayo Clinic Florida

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Allergy Skin Patch Testing

Arm Description

On day 1, subjects will have a allergy skin patch test applied and a routine skin examination. On day 3, the patch test will be removed and documentation of the test sites using iPhone app. On day 5, the final assessment for allergic contact dermatitis will be conducted by a medical professional.

Outcomes

Primary Outcome Measures

AI algorithms predictions of reactions
Number of times the AI algorithms matches the human review of photographs of skin patch tests classification of reaction. The accuracy for the classification of regions within the test panel that either were a reaction (reaction grade 1+) or not (grade 0).

Secondary Outcome Measures

Fitzpatrick skin type assessment
Number of times the AI algorithms matches the human review of photographs of skin patch tests over the entire range of Fitzpatrick skin types. The Fitzpatrick skin typing categorize skin type according to how much melanin is present.

Full Information

First Posted
April 4, 2022
Last Updated
January 4, 2023
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT05339750
Brief Title
Allergy Skin Patch Artificial Intelligence (AI)
Official Title
Democratization of Allergy Skin Patch Testing to Increase Efficiency and Scale of the Practice
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
February 15, 2022 (Actual)
Primary Completion Date
September 23, 2022 (Actual)
Study Completion Date
September 23, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this research is to assess human and artificial intelligence performance in grading contact dermatitis reactions in healthy volunteers.
Detailed Description
Study participation involves three visits to the study site on Days 1, 3, and 5, and completion of a demographics and allergy history questionnaire. Researchers will review medical history and current medications. On Day 1 a patch will be applied with 10 allergens and a routine skin examination will be conducted and a photograph will be taken of the forearm. On day 3, subjects will return to remove the patch test and have photographs of the area taken. On day 5, the final assessment for allergic contact dermatitis will be performed and photographs of the area taken. Key Information: The most common side effect of skin testing is slightly swollen, red, itchy bumps (wheals). These wheals may be most noticeable during the test. In some, an area of swelling, redness and itching may develop a few hours after the test and remain for a couple of days. Rarely, allergy skin tests can produce a severe, immediate allergic reaction. The patches are worn on the forearm for 48 hours. During this time, bathing and activities that cause heavy sweating should be avoided. Irritated skin at the patch site may indicate an allergy. If a positive test result is documented, a medical professional will provide education and recommend follow up with primary care provider.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Contact Dermatitis

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
233 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Allergy Skin Patch Testing
Arm Type
Experimental
Arm Description
On day 1, subjects will have a allergy skin patch test applied and a routine skin examination. On day 3, the patch test will be removed and documentation of the test sites using iPhone app. On day 5, the final assessment for allergic contact dermatitis will be conducted by a medical professional.
Intervention Type
Device
Intervention Name(s)
AI-based smartphone application
Intervention Description
AI-based smartphone application to record and interpret the patch test results
Intervention Type
Diagnostic Test
Intervention Name(s)
Allergen patch
Intervention Description
Allergens applied to a patch which is placed on the skin on the forearm region. The patch contains 10 dime-sized disks which contain a different allergen.
Primary Outcome Measure Information:
Title
AI algorithms predictions of reactions
Description
Number of times the AI algorithms matches the human review of photographs of skin patch tests classification of reaction. The accuracy for the classification of regions within the test panel that either were a reaction (reaction grade 1+) or not (grade 0).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Fitzpatrick skin type assessment
Description
Number of times the AI algorithms matches the human review of photographs of skin patch tests over the entire range of Fitzpatrick skin types. The Fitzpatrick skin typing categorize skin type according to how much melanin is present.
Time Frame
10 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria Adults over the age of 18 Willing and able to provide informed consent Exclusion Criteria Under 18 years of age Has used topical or oral steroids two weeks prior to patch testing Currently taking immunosuppression agents or is immunocompromised due to medical condition No sunburn or rash at site of testing Women who are breastfeeding or pregnant. Treatment with ultraviolet (UV) light (including tanning) during the two weeks prior to visit. Subjects unable to comply with patch test study requirements including multiple return visits and activity restrictions (e.g., protecting patch test area from excess moisture due to showering)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Hall, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

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Allergy Skin Patch Artificial Intelligence (AI)

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